Sutent and Radiation as Treatment for Limited Extent Metastatic Cancer
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|ClinicalTrials.gov Identifier: NCT00463060|
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Cancer is the second leading cause of death in the United States, with approximately 90% of deaths resulting from patients with metastatic spread. Save for notable exceptions such as testicular cancer, chemotherapy alone cannot cure patients with metastases. Some patients with limited metastatic deposits (most commonly colon cancer spread to the liver) can be cured with surgery followed by chemotherapy. Therefore, some patients with metastases should be considered for aggressive local therapy (surgery and/or radiation).
Even though chemotherapy has improved significantly, patients treated with conventional chemotherapy and/or biologically targeted therapy are not cured of their disease. For the most common types of cancer, chemotherapy alone can shrink or stabilize tumors for an average of 6 months before the tumors regrow. Both chemotherapy and biologically targeted therapy have major limitations preventing cure of these patients.
Radiation therapy is an effective modality of treating cancer. Until recently, radiation for metastases was used only to relieve symptoms resulting from local tumor growth. Technological advances, including stereotactic radiotherapy, allow for radiation to be more precisely delivered to the tumor while sparing nearby normal organs. Stereotactic radiotherapy can completely eradicate local tumors with minimal side effects. Stereotactic radiotherapy has never been combined with drug therapy. Sutent is a new F.D.A. approved cancer therapy that targets tumor blood vessels. It is effective against two types of cancer that rarely respond to chemotherapy (GI stromal tumors and kidney cancer). We propose combining biologically targeted drug therapy with physically targeted stereotactic radiotherapy. Our goal is to determine if this is a safe regimen and the best method of combining these treatments. Ultimately, our goal is to cure some patients with previously incurable metastatic cancer with this combination.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: sunitinib malate (Sutent) Procedure: radiotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Stereotactic Radiation Therapy and Concurrent and Adjuvant Sutent (SU11248) as Treatment for Oligometastatic Disease|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Participants treated with chemotherapy and radiotherapy
Drug: sunitinib malate (Sutent)
Sutent administered PO QD from days 1 to 28 Two weeks after completion of any chemotherapy, maintenance Sutent in 6 week cycles (consisting of Sutent 50 mg PO QD weeks 1-4 followed by no treatment weeks 5-6) until progression or death If no chemotherapy is planned, maintenance Sutent (as described above) will start on day 43.
Radiation is to be delivered to each site over 10 fractions separated by at least 16 hours. Up to 5 sites may be treated
Other Name: XRT
- Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: 2 years ]Sunitinib (SU) and radiation (IGRT) doses were sequentially escalated using a ping-pong strategy according to a 3 + 3 design phase 1 study. The starting dose was sunitinib 25 mg and IGRT 40 Gy. MTD reflects the highest dose that did not cause a dose limiting toxicity. Toxicity was in assessed in patients at regular intervals by using the Common Terminology Criteria for Adverse Events criteria (version 3.0). Dose limiting events were defined as any grade 4 or 5 toxicity and unexpected grade 3 toxicity. Expected grade 3 toxicities from radiation include mucositis or esophagitis lasting ≤7 days. Grade 3 metabolic and hematologic toxicities are considered expected events with sunitinib and therefore were not considered DLTs
- Number of Participants With Particular Disease Status [ Time Frame: 5 years ]Number of participants who have no evidence of disease and number of participants with distant metastases.
- Percentage of Patients With Toxicity Grade 3 or Higher [ Time Frame: 5 years ]% of patients experienced one or more grade ≥ 3 toxicities. Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4),and death (Grade 5).
- Percentage of Patients With Local Control [ Time Frame: 4 years ]Local control was defined as a tumor volume equal to or less than the tumor volume at start of radiotherapy.
- Percentage of Patients With Distant Control [ Time Frame: 4 weeks ]Distant control defined as distant metastasis contained outside of the radiation field within months of treatment.
- Quality of Life [ Time Frame: 4-6 weeks after radiation therapy ]
- Number of Participants According Failure and Survival [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463060
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Max Sung, MD||Icahn School of Medicine at Mount Sinai|